In This Issue
· District
Court Finds Inducement To Infringe Found In Doxercalciferol® Case
· Federal
Circuit Upholds First Post- Therasense Inequitable Conduct Ruling In Taxotere® Case
Contact Us:
www.gbpatent.com
gbpatent@gbpatent.com
703-716-1191 (phone)
703-716-1180 (fax) |
District Court Finds Inducement To Infringe In Doxercalciferol® Case
The U.S. District Court for
the District of Delaware recently held, inter
alia, in Bone Care Int'l v. Roxane
Labs., that the ANDA applicants’, i.e.,
Roxane, Sandoz, and Anchen, generic products would induce infringement of
claim 7 of U.S. Patent No. 5,602,116 (“the ‘116 patent”), and that the claim
was not invalid. This litigation stems
from the applicants ANDA containing a paragraph IV certification seeking
approval to market generic version of Hectorol® (doxercalciferol), which is
indicated and approved for the treatment of secondary hyperparathyroidism (“SHPT”)
in patients with end-stage renal disease (“ESRD”).
The District Court conducted a Markman hearing and in relevant
part, construed the term "effective amount of doxercalciferol to lower
and maintain lowered serum parathyroid hormone levels" to mean "an
amount of doxercalciferol sufficient to lower and maintain lowered blood
concentrations of PTH with a lower incidence of hypercalcemia than would
result from using calcitriol or alfacalcidol to achieve the same level of PTH
suppression." The District Court
thereafter undertook the inducement to infringement analysis first concluding
that claim 7 would be directly infringed by applicants' ANDA products. After making this necessary underlying finding
for inducement to infringe, the District Court turned to the second prong of
the test; that is, whether applicants had the requisite specific intent to
induce infringement.
The intent question turned on
whether applicants intended to induce infringement of claim 7; despite the
fact that the proposed ANDA labeling did not discuss or compare the incidence
of hypercalcemia resulting from doxercalciferol as opposed to those from
calcitriol or alfacalcidol. To answer
this question, the District Court first noted that (although the threshold infringement
question in Hatch-Waxman litigations is "whether the proposed label
instructs users to perform the patented method," and
"promotes" or "encourages" others to practice that method) the Federal Circuit has held that
inducement to infringe also requires a showing of evidence that the applicant
"knew or should have known that his actions would induce actual
infringement" and "that the induced acts constitute patent
infringement." That is, the
Federal Circuit has held that inducement required determining whether the
proposed label "instructs users to perform the patented method" and
"teaches an infringing use . . . such that we are willing to infer from
those instructions an affirmative intent to infringe the patent."
The District Court then
turned to the facts at-hand and concluded that the Bone Care had shown that
applicants "knew or should have known their actions would induce actual
infringements," because all of the ANDAs sought approval to market a
doxercalciferol product with a label directing physicians and medical
professionals to administer in accordance with the claimed method; the
FDA-approved indication is the same use set forth in the claim. The District Court, in making this finding,
also relied upon publically available clinical trials and literature to show
that applicants knew or should have known that doxercalciferol has been shown
to lower and maintain PTH levels with a diminished incidence of hypercalcemia
than would result from using calcitriol or alfacalcidol at the same level of
PTH suppression.
Federal Circuit Upholds First Post-Therasense Inequitable Conduct Ruling In Taxotere® Case
The Federal Circuit recently
affirmed the ruling by the U.S. District Court for the District of Delaware
in Aventis Pharma v. Hospira that
U.S. Patent No. 5,750,561 (“the ‘561 patent”) and U.S. Patent No. 5,714,512
(“the ‘512 patent”) (collectively “the Aventis patents”) were, inter alia, unenforceable for
inequitable conduct. After a bench
trial, the District Court held the Aventis patents unenforceable prior to the
Federal Circuit’s ruling in Therasence which changed the standard for inequitable conduct, as well as holding certain
asserted claims invalid as obvious and/or non-infringed.
The Aventis patents are
directed to the chemotherapy drug Taxotere®, i.e., formulations of the cancer drug docetaxel that minimize
stability and toxicity problems in prior art formulations with certain
surfactants/excipients and limited ethanol. The District Court held the Aventis patents unenforceable based upon
the intentional non-disclosure of a publication by Guéritte-Voegelein (“the
GV reference”) and the Dictionnaire Vidal (“the Vidal reference”).
In affirming the District
Court, the Federal Circuit expressly noted that “although the district court
did not have the benefit of our Therasense opinion when it rendered its
inequitable conduct decision, . . . we conclude [based upon an analysis of
both the materiality and intent to deceive prongs of the inequitable conduct
test] that the [district] court’s inequitable conduct determination
withstands even the more rigorous standard adopted in Therasense.”
With respect to analysis
itself, the Federal Circuit first addressed the materiality prong observing
that the inequitable conduct assertions were based upon the exact same two
invalidating references, and that under Therasense,
the invalidity rulings establish that the GV and Vidal references meet the
“but for” test for materiality. In so
doing, the Federal Circuit quoted the following passage from Therasense:
[W]hen a “claim is properly
invalidated in district court based on the deliberately withheld reference,
then that reference is necessarily material” for purposes of the inequitable
conduct inquiry.
The Federal Circuit then
turned its attention to the intent prong noting the test, which requires that:
(1) the accused infringer prove by clear and convincing evidence that
applicant knew of the reference, knew that it was material, and made a
deliberate and intentional decision to withhold it; and (2) applicant’s
specific intent to deceive must be “the single most reasonable inference able
to be drawn from the evidence.”
With regard to the Vidal
reference, the Federal Circuit agreed with the District Court discounting, as
not credible, the inventor’s testimony that he believed that it was not
necessary to disclose the Vidal reference because his related experiments
were “failures.” In so doing, the
Federal Circuit relied upon the grounds that the inventor himself provided
contradictory testimony elsewhere that he learned from the Vidal reference to
replace the prior art surfactant with the claimed surfactant, and that the
Vidal reference was a “main factor” in replacing the surfactant, which both
noted “was consistent with [an Aventis] internal memorandum.” The Federal Circuit also joined in the
District Court’s concerns that the inventors had mischaracterized the Vidal
reference as recognizing a problem with the prior art surfactant but not a
possible solution, in holding that the inventors acted with intent because
they “knew that the Vidal reference and the other etoposide prior art were
relevant to the patentability of his alleged invention, but nonetheless chose
not to disclose it to the patent office.”
The
Federal Circuit also agreed with the District Court in finding not credible
the inventor’s testimony that he did not disclose the GV reference because he
only had read a draft that did not include the most relevant passage because, inter alia, the inventor: (1) “was
the project leader;” (2) “had to approve the GV reference for publication;”
and (3) “had testified that he reviewed the article ‘with some care to make
sure that it was a proper article for the company to be publishing.’” The Federal Circuit further observed as did
the District Court the inventor’s testimony that he took steps to revise the
clinical brochure for Taxotere® because it did not list the GV reference, yet
did not disclose the GV reference to the U.S. Patent Office.
In view of the above, the
Federal Circuit held that “the district court heard extensive testimony from
inventor Fabre regarding both the Vidal and GV references, and the court’s
finding that Fabre acted with a specific intent to deceive the PTO in
withholding those references is not clearly erroneous.” |